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dementia.",[13],"Device: ALZGUARD",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ALZGUARD","A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rachel Lee","CONTACT","+82 10-7390-5023","rachel.lee@haii.io",[28,49,65],{"facility":29,"status":30,"city":31,"state":32,"zip":20,"country":33,"countryCode":20,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Kangwon National University Hospital","RECRUITING","Chuncheon","Gangwon-do","South Korea",{"type":35,"coordinates":36},"Point",[37,38],127.73417,37.87472,{"lat":38,"lon":37},[41,44,47],{"name":42,"role":24,"phone":20,"phoneExt":20,"email":43},"YeShin Kim","yeshins@gmail.com",{"name":45,"role":24,"phone":20,"phoneExt":20,"email":46},"KungHee 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Jeon","myc5198@gmail.com",{"name":75,"role":24,"phone":20,"phoneExt":20,"email":76},"JiSu Jeong","xodud1234@yuhs.ac",{"name":72,"role":48,"phone":20,"phoneExt":20,"email":20},{"type":79,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100563361","confirmatory-clinical-trial-for-verifying-the-efficacy-and-safety-of-alzguard-as-a-digital-dementia-diagnostic-aid-tool-for-the-diagnosis-of-the-major-neurocognitive-disorders-100563361",false,"NCT06615167","Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders","A Single-blind (Data Analyst 1), Single-arm Design, Prospective, Multi-center Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders According to DSM-5","Inclusion Criteria:\n\n* Participants must be between 55 and 85 years old (both men and women).\n* Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.\n\nExclusion Criteria:\n\n* Participants with no literacy or illiteracy.\n* Participants with an intellectual disability.\n* Participants with presenting active psychiatric symptoms.\n* Participants who have difficulty ALZGUARD application\n* Participants who are unable to use a smartphone, unless they can use it with assistant.\n* Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.\n* Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI).","ALL","55 Years","85 Years",{"count":91,"type":92},122,"ESTIMATED","INTERVENTIONAL",[95],"NA","The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.",[98,99],"Dementia","Major Neurocognitive Disorder","2024-09-25",{"date":102,"type":103},"2024-09-26","ACTUAL",{"date":105,"type":103},"2024-09-12",{"date":107,"type":92},"2025-04-30",{"name":5,"class":6},3]